ABSTRACT
ReFacto consists of a recombinant coagulation factor VIII that lacks most of the B domain of the natural protein, thus reducing the size of the natural molecule by about 40%. The recombinant protein retains the activity of the natural protein but has the advantage of being easier to produce. The gene encoding the recombinant molecule is cloned, and the protein is expressed in CHO cells. After processing and glycosylation, the protein is secreted into the culture medium. Purification involves chromatographic steps, including immunoaffinity chromatography using a murine monoclonal antibody raised against the protein. Viral inactivation steps are also included during downstream processing. The purified product is lyophilized. No human serum albumin is added for
Overview of Therapeutic Properties
The coagulation factor VIII is involved in the blood coagulation process. Once activated, it accelerates the conversion of factor X by acting as a cofactor for factor IX. Factor X activates prothrombin to form thrombin, which is necessary to convert fibrinogen into fibrin to form the clot.
